Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome

Official title

Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled Trial

Overview

The present study evaluates whether performing a 14-days counter pressure maneuvers (CPM)-biofeedback training improves the symptomatic burden (primary objective) and secondarily the interference of POTS symptoms with daily activities, fatigue, and health-related quality of life of individuals with POTS compared to best clinical practice non-pharmacological measures. Secondary in-laboratory objectives are to assess the influence of CPM on the supine-to-standing heart rate (HR) and blood pressure (BP) changes as well as on the severity of orthostatic intolerance after performing CPM for two minutes compared to a baseline (intervention-free) active standing test, and to assess the safety and tolerability of CPM-biofeedback training in individuals with POTS. This is a monocentric, proof-of-concept, 1:1 randomized, controlled trial with rater-blinded evaluation of the hemodynamic effect of CPM in 40 individuals suffering from POTS. All study participants will receive detailed counselling on CPM and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life and will be invited to practice them regularly (best clinical practice). Participants randomized to the interventional arm will receive a CPM-biofeedback training session in the autonomic function laboratory at the Department of Neurology of the Innsbruck Medical University to learn four different CPM under continuous HR and BP monitoring. The CPM-biofeedback training will consist of a baseline 2-minutes active standing and the following four different physical maneuver: leg crossing and muscle tensing, heel raises (10 tiptoeing per minute), squatting, unilateral handgrip (20 times a minute). The trial foresees three study visits for both the interventional and the control arm (screening and baseline on-site, as well as a telephone visit 14 days later). For the interventional trial arm, two additional visits are planned (CPM-biofeedback training session in the autonomic function laboratory and a follow-up telephone visit 7 days later). To evaluate the baseline to day-14 change in symptom severity, the Malmö POTS Score (MAPS) total score (primary endpoint) and the MAPS single items, Vanderbilt Orthostatic Symptom Score, Orthostatic Grading Scale, Fatigue Severity Scale and Health-related Quality of Life Questionnaire (EuroQol -EQ-5D-5L ) will be administered.

Interventions

• Behavioral Best clinical practice plus CPM-biofeedback training
  The CPM-biofeedback training consists of a baseline 2-minutes active standing and the following four different physical maneuver: leg crossing and muscle tensing, heel raises (10 tiptoeing per minute), squatting, unilateral handgrip (20 times per minute). All exercises will be performed under continuous heart rate and blood pressure monitoring to enable the study participants to gain feedbacks on the effect of the maneuvers on their own biosignals.
• Other Best clinical practice
  Recommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life.

Primary outcome measures

• Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS) [Time frame: Baseline to day-14]

Secondary outcome measures (12)

• Severity of orthostatic intolerance (on a 0 - 10 points scale) [Time frame: After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.]
• Absolute heart rate [Time frame: At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver practiced upon standing , at day 1 +/-3.]
• Absolute systolic and diastolic blood pressure [Time frame: At 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing, , at day 1 +/-3.]
• Supine-to-standing change in heart rate [Time frame: At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.]
• Supine-to-standing change in systolic and diastolic blood pressure [Time frame: At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.]
• Single items of the Malmö POTS Score (MAPS) [Time frame: Baseline to day-14]
• Vanderbilt Orthostatic Symptom Score (VOSS) [Time frame: Baseline to day-14]
• Orthostatic Grading Scale (OGS) [Time frame: Baseline to day-14]
• Fatigue Severity Scale (FSS) - german Version [Time frame: Baseline to day-14]
• European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version) [Time frame: Baseline to day-14]
• Estimated number and preferred choice of counterpressure maneuvers in daily life [Time frame: Baseline to day-14]
• Overall usefulness of counterpressure maneuvers [Time frame: Baseline to day-14]

Eligibility criteria

Inclusion criteria

• POTS diagnosis
• 18 to 80 years of age at time of consent
• stable medication in the seven days prior to the baseline visit
• able to provide written informed consent

Exclusion criteria

• participation in other interventional trials
• pregnant or breastfeeding females
• on treatment with vasoactive medications including medications for heart rate control
• acute infections at the time of enrolment or in the two weeks before
• acute pain
• surgery in the last three months
• inability or contraindication for performing hip and knee flexion, hip adduction or squatting
• inability to stand for at least two minutes
• Any other cardiological, internal, psychiatric or neurological condition, which may prevent engagement in the sturdy procedures in the judgement of the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Austria · 1 center

• Medical University of Innsbruck — Innsbruck

Identifiers

NCT: NCT06936319 · 20241114-3611

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗